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X-MIND trium XMT PAN R

by De Götzen SRL

X-MIND trium XMT PAN R (W0900001) is a Class II device made by De Götzen SRL, cleared under FDA 510(k) K160166 on 15 Nov 2016 and listed in FDA GUDID since 15 Dec 2016 (UDI-DI D804W09000010), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K160166

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD804W09000010 UDI-DI Date15 Dec 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK160166 Date15 Nov 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K160166 decided 15 Nov 2016 Active
  • FDA GUDID UDI-DI D804W09000010 listed 15 Dec 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K160166
  2. Listed FDA GUDID D804W09000010

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
X-MIND trium
Generic name
Stationary panoramic/tomographic dental x-ray system, digital
Model / Ref / Catalog
XMT PAN R, W0900001
Primary DI / UDI-DI
D804W09000010
510(k) Number
FDA product code
OAS, MUH
GMDN term
Stationary panoramic/tomographic dental x-ray system, digital
Device class
Class II
Regulation number
892.1750, 872.1800
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code OAS (X-Ray, Tomography, Computed, Dental).

Other devices from De Götzen SRL

See all devices from De Götzen SRL →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)